Overview


According to FutureWise analysis, the market for Materiovigilance is expected to grow with a CAGR of 8.2% over the forecast period 2024-2032, and reach a market value of US$ 146.08 billion by 2031.

Materiovigilance is a term used in the context of medical devices and refers to the surveillance and monitoring of the security and performance of medical devices placed on the market. It is similar in concept to pharmacovigilance, which is the monitoring of the safety of pharmaceutical drugs. The goal of materiovigilance is to ensure the ongoing safety and effectiveness of medical devices throughout their whole lifecycle, from design and production to use by patients. This involves collecting, evaluating, and reporting information about adverse events, malfunctions, or any other issues related to medical devices. Regulatory authorities, like the European Medicines Agency in Europe and the FDA in the United States, play a vital role in overseeing materiovigilance activities. They establish guidelines, review reports, and take regulatory actions if necessary.

To effectively manage and regulate this process, it is crucial to categorize end users into distinct groups. These groups play distinctive roles in the production, testing, and distribution of medical devices. Contract Research Organizations (CROs) are key players in the healthcare industry, providing specialized research services to pharmaceutical, biotechnology, and medical device companies. In materiovigilance, CROs are instrumental in conducting clinical trials and post-market surveillance studies. Business Process Outsourcing (BPO) companies play a vital role in supporting various functions within the healthcare industry. When it comes to materiovigilance, BPOs often handle administrative tasks, data entry, and documentation processes. They serve as a valuable extension of medical device companies, ensuring that all necessary information related to the safety and performance of devices is accurately recorded and maintained. Original Equipment Manufacturers (OEMs) are the cornerstone of medical device production. They design, manufacture, and assemble the devices that ultimately reach healthcare professionals and patients. Materiovigilance is important to OEMs, as they bear the prior responsibility for the quality and safety of their products.

FutureWise Market Research has published a report that provides an insightful analysis materiovigilance market trends that are affecting the overall market growth. This report will provide a detailed analysis of market share, regional insights, and competitor analysis that includes stature of key manufacturers operational in this industry. According to the analysis conducted by FutureWise research analysts materiovigilance market estimated to register a considerable growth rate over the forecast period. This report lists the market segments and potential prospects available across this industry, in addition providing crucial information on the total valuation currently held by the industry. Moreover, this report will assist key management individuals in an organisation to enhance their decisions pertaining to business expansion as well as strategic changes for increasing customer base.

  • AssurX
  • Sparta Systems   
  • Oracle Corporation
  • Xybion Corporation
  • Sarjen Systems Pvt. Ltd.
  • MDI Consultants
  • AB-Cube
  • QVigilance
  • Qserve
  • ZEINCRO

(Note: The list of the major players will be updated with the latest market scenario and trends)

The increasingly stringent regulations regarding medical device safety and reporting standards drive the demand for the materiovigilance market. As authorities heighten their scrutiny on the safety and efficacy of medical devices, companies are compelled to implement robust materiovigilance solutions to ensure compliance. This surge in regulatory requirements catalyzes the market forward as businesses seek advanced systems to monitor and report adverse events effectively, thereby fostering a safer and more reliable healthcare ecosystem. In addition, the materiovigilance market is poised for significant growth, propelled by a significant rise in medical device recalls due to technical defects. This uptick underscores the critical need for advanced monitoring and reporting systems as manufacturers and healthcare facilities increasingly recognize the necessity of quickly and precisely identifying defective devices. This trend not only amplifies the demand for materiovigilance solutions but also underscores their pivotal role in averting potential risks, safeguarding patient well-being, and upholding the integrity of the broader healthcare landscape. Moreover, rapid technological advancements, especially in data analytics and artificial intelligence, are revolutionizing the monitoring and analysis of adverse events linked to medical devices. These advancements empower the healthcare industry with unprecedented capabilities to swiftly identify, assess, and respond to potential risks associated with medical devices. By utilizing sophisticated algorithms and real-time data processing, materiovigilance solutions are becoming increasingly adept at providing actionable insights, bolstering patient safety, and reinforcing regulatory compliance efforts. However, the adoption of materiovigilance systems may face significant barriers, particularly for smaller manufacturers or healthcare facilities, as the implementation costs might be prohibitively high. This financial strain poses a substantial hurdle, potentially limiting access to these crucial safety measures for smaller players in the market. Also, in certain regions or among smaller enterprises, a lack of awareness exists regarding the paramount importance of materiovigilance. Therefore, this shortage of adequately trained personnel further hinders the seamless integration and effective management of materiovigilance processes.

By Delivery Mode

  • On-premise
  • On-cloud

By Application 

  • Diagnostic Application
  • Therapeutic Application
  • Surgical Application
  • Research Application
  • Others

By End Users

  • Contract Research Organization
  • Business Process Outsourcing
  • Original Equipment Manufacturers
  • Others

By Region

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East and Africa

This market research report also emphasis on factors affecting the growth rate in various regions listed above. A deep-down analysis of region will also be provided in the final version of this market which is based on conclusion of primary interviews and secondary data point gathered during the process.

By region, the market is segmented into North America, Latin America, Europe, Asia-Pacific, and Middle East & Africa. North America registered highest share in the market in 2022. This is primarily attributed to factors such as increased releases of medical device security programs, increased R&D activities, and major companies in the industry participating in strategic acquisitions and mergers, alliances, and new product launches in the region, which is projected to bolster the growth of the market over the forecast period. Additionally, the increase in the number of medical device recalls due to technical faults will further propel the materiovigilance market during the projection period. For instance, as per the data published by the Medical Device and Diagnostic Industry, which exclusively serves original equipment manufacturers of medical devices and in-vitro diagnostic products, the number of medical device recalls issued in June 2021 was greater than the first half of each of the preceding five years.

  • Tier 1 players- established companies in the market with a major market share
  • Tier 2 players
  • Emerging players which are growing rapidly
  • New Entrants

  • Growth prospects
  • SWOT analysis
  • Key trends
  • Key data-points affecting market growth

  • To provide with an exhaustive analysis on the Materiovigilance Market By Delivery Mode, By Application, By End Users, and By Region
  • To cater comprehensive information on factors impacting market growth (drivers, restraints, opportunities, and industry-specific restraints)
  • To evaluate and forecast micro-markets and the overall market
  • To predict the market size, in key regions— North America, Europe, Asia Pacific, Latin America and Middle East and Africa.
  • To record and evaluate competitive landscape, mapping- product launches, technological advancements, mergers and expansions

  • We have a flexible delivery model and you can suggest changes in the scope/table of content as per your requirement
  • The customization Mobility Care offered are free of charge with purchase of any license of the report
  • You can directly share your requirements/changes to the current table of content to: sales@futurewiseresearch.com

Table of Contents


  • 1.  Market Introduction
    •   1. Objectives of the Study 
        2. Market Definition 
        3. Market Scope 
           3.1. Years Considered for the Study
           3.2. Market Covered
        4. Currency 
        5. Limitations 
        6. Stakeholders 

  • 2.  Research Methodology
    •   1. Research Data 
           1.1. Secondary Data
              1.1.1. Key Data from Secondary Sources
           1.2. Primary Data
              1.2.1. Key Data from Primary Sources
        3. Market Size Estimation 
        4. Market Breakdown and Data Triangulation 
        5. Assumptions for the Study 

  • 3.  Executive Summary
    •   1. Market Outlook
        2. Segment Outlook
        3. Competitive Insights

  • 4.  Materiovigilance Market Variables, Trends & Scope
    •   1. Market Lineage Outlook
        2. Penetration and Growth Prospect Mapping
        3. Industry Value Chain Analysis
        4. Cost Analysis Breakdown
        5. Application Overview
        6. Regulatory Framework
           6.1. Reimbursement Framework
           6.2. Standards and Compliances

  • 5.  Market Overview
    •   1. Market Dynamics
           1.1. Market Driver Analysis
              1.1.1. Increasing focus of Materiovigilance Market Companies on Brand Protection
              1.1.2. Untapped Opportunities in Emerging Regions
           1.2. Market Restraint Analysis
              1.2.1. High Cost Associated with Implementation of Predictive Analysis
           1.3. Industry Challenges
              1.3.1. Presence of Ambiguous Regulatory Framework

  • 6.  Materiovigilance Market Analysis Tools
    •   1. Industry Analysis - Porter’s
           1.1. Supplier Power
           1.2. Buyer Power
           1.3. Substitution Threat
           1.4. Threat from New Entrants
           1.5. Competitive Rivalry
        2. Pestel Analysis
           2.1. Political Landscape
           2.2. Environmental Landscape
           2.3. Social Landscape
           2.4. Application Landscape
           2.5. Legal Landscape
        3. Major Deals And Strategic Alliances Analysis
           3.1. Joint Ventures
           3.2. Mergers and Acquisitions
           3.3. Licensing and Partnership
           3.4. Application Collaborations
           3.5. Strategic Divestments
        4. Market Entry Strategies
        5. Case Studies

  • 7.  Materiovigilance Market, By Delivery Mode Historical Analysis and Forecast 2024-2032 (USD Million)
    •   1. On-premise
        2. On-cloud

  • 8.  Materiovigilance Market, By Application Historical Analysis and Forecast 2024-2032 (USD Million)
    •   1. Diagnostic Application
        2. Therapeutic Application
        3. Surgical Application
        4. Research Application
        5. Others

  • 9.  Materiovigilance Market, By End Users Historical Analysis and Forecast 2024-2032 (USD Million)
    •   1. Contract Research Organization
        2. Business Process Outsourcing
        3. Original Equipment Manufacturers
        4. Others

  • 10.  North America Materiovigilance Market Analysis 2018-2023 and Forecast 2024-2032 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2018-2023
           2.1. U.S.A
           2.2. Canada
           2.3. Mexico
        3. Market Size (USD Million) Forecast for North America 2024-2032

  • 11.  Latin America Materiovigilance Market Analysis 2018-2023 and Forecast 2024-2032 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2018-2023
           2.1. Brazil
           2.2. Venezuela
           2.3. Argentina
           2.4. Rest of Latin America
        3. Market Size (USD Million) Forecast for Latin America 2024-2032

  • 12.  Europe Materiovigilance Market Analysis 2018-2023 and Forecast 2024-2032 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2018-2023
           2.1. Germany
           2.2. U.K
           2.3. France
           2.4. Italy
           2.5. Spain
           2.6. Russia
           2.7. Poland
           2.8. Rest of Europe
        3. Market Size (USD Million) Forecast for Europe 2024-2032

  • 13.  Asia Pacific Materiovigilance Market Analysis 2018-2023 and Forecast 2024-2032 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2018-2023
           2.1. Japan
           2.2. China
           2.3. India
           2.4. Australia and New Zealand
           2.5. ASEAN
           2.6. Rest of Asia Pacific
        3. Market Size (USD Million) Forecast for Asia Pacific 2024-2032  

  • 14.  Middle East and Africa Market Analysis 2018-2023 and Forecast 2024-2032 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2018-2023
           2.1. GCC
           2.2. Israel
           2.3. South Africa
           2.4. Rest of MEA
        3. Market Size (USD Million) Forecast for MEA 2024-2032

  • 15.  Market Share Analysis and Competitive Landscape
    •   1. Global Landscape - Key Players, Revenue and Presence
        2. Global Share Analysis - Key Players (Tier 1, Tier 2, Tier 3)
        3. Global Emerging Companies
        4. North America - Market Share Analysis and Key Regional Players
        5. Europe - Market Share Analysis and Key Regional Players
        6. Asia Pacific - Market Share Analysis and Key Regional Players
        7. Global Key Player - Growth Matrix

  • 16.  Company Profiles (Competition Dashboard, Competitors Deep Dive, Products Offered and Financial Layouts)
    •   1. AssurX
           1.1. Company Overview
           1.2. Product Portfolio
           1.3. SWOT Analysis
           1.4. Financial Overview
           1.5. Strategic Overview
        2. Sparta Systems
           2.1. Company Overview
           2.2. Product Portfolio
           2.3. SWOT Analysis
           2.4. Financial Overview
           2.5. Strategic Overview
        3. Oracle Corporation
           3.1. Company Overview
           3.2. Product Portfolio
           3.3. SWOT Analysis
           3.4. Financial Overview
           3.5. Strategic Overview
        4. Xybion Corporation
           4.1. Company Overview
           4.2. Product Portfolio
           4.3. SWOT Analysis
           4.4. Financial Overview
           4.5. Strategic Overview
        5. Sarjen Systems Pvt. Ltd.
           5.1. Company Overview
           5.2. Product Portfolio
           5.3. SWOT Analysis
           5.4. Financial Overview
           5.5. Strategic Overview
        6. MDI Consultants
           6.1. Company Overview
           6.2. Product Portfolio
           6.3. SWOT Analysis
           6.4. Financial Overview
           6.5. Strategic Overview
        7. AB-Cube
           7.1. Company Overview
           7.2. Product Portfolio
           7.3. SWOT Analysis
           7.4. Financial Overview
           7.5. Strategic Overview
        8. QVigilance
           8.1. Company Overview
           8.2. Product Portfolio
           8.3. SWOT Analysis
           8.4. Financial Overview
           8.5. Strategic Overview
        9. Qserve
           9.1. Company Overview
           9.2. Product Portfolio
           9.3. SWOT Analysis
           9.4. Financial Overview
           9.5. Strategic Overview
        10. ZEINCRO
           10.1. Company Overview
           10.2. Product Portfolio
           10.3. SWOT Analysis
           10.4. Financial Overview
           10.5. Strategic Overview

  • 17.  Pre and Post COVID-19 Impact
    •   1. Positive influence on the healthcare industry
        2. The financial disruption of the manufacturing sector
        3. Impact of COVID-19 on emerging companies
        4. Significant mandates in the healthcare regulations initiated
      by administrations
        5. The overall economic slowdown of the developing and developed nations

  • 18.  FutureWise SME Key Takeaway Points for Client
    •   

Partner

Our Clients